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    Rezolute (RZLT) Misses Key CHI Endpoints: Does Ersodetug’s TIH Pivot Rewrite The Drug’s Story?

    Simply Wall St·12/19/2025 14:22:54
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    • Rezolute, Inc. recently reported topline Phase 3 sunRIZE results for ersodetug in congenital hyperinsulinism, with the trial failing to meet its primary and key secondary endpoints and showing some safety concerns, including rare serious hypersensitivity reactions.
    • Despite the missed endpoints, the highest ersodetug dose produced a hypoglycemia reduction similar to placebo and the company continues to advance the related upLIFT Phase 3 study in tumor-induced hyperinsulinism, highlighting ongoing efforts to find broader applications for the drug’s downstream mechanism.
    • We’ll explore how the mixed efficacy signals, particularly the non-significant hypoglycemia reduction at the top dose, reshape Rezolute’s investment narrative.

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    What Is Rezolute's Investment Narrative?

    For Rezolute to make sense in a portfolio, you have to believe ersodetug can still find a commercially meaningful niche in hyperinsulinism despite the Phase 3 sunRIZE setback. The failed congenital HI study directly hits the original cornerstone of the story and helps explain the very large recent share price swing, but it does not completely erase the downstream, “universal HI” thesis, especially with the tumor-induced HI upLIFT trial still running as the next major catalyst. In the near term, the key questions shift from peak opportunity to regulatory tolerance for mixed efficacy and safety, and to Rezolute’s ability to fund operations after an equity raise and prior dilution. With no revenue, ongoing losses and a stock trading well below some analyst fair value estimates, execution risk and financing risk now sit front and center, with sunRIZE as a reminder of binary trial outcomes.

    However, investors should watch how Rezolute manages cash burn and any further dilution from here. Rezolute's shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.

    Exploring Other Perspectives

    RZLT 1-Year Stock Price Chart
    RZLT 1-Year Stock Price Chart

    Three fair value views from the Simply Wall St Community span about US$4.13 to roughly US$12.81 per share, showing how differently investors are weighing the HI opportunity against trial and funding risk. Taken together with the recent Phase 3 miss and Rezolute’s ongoing losses, this spread underlines why it can help to compare several independent viewpoints before forming your own expectations for the company’s path forward.

    Explore 3 other fair value estimates on Rezolute - why the stock might be worth just $4.12!

    Build Your Own Rezolute Narrative

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    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.